Principal Quality Engineer

Company: Cala Health
Location: San Mateo
Posted on: June 19, 2022

Job Description:

Our DNAWe're here to empower people to experience greater control over their chronic conditions and more freedom in their daily lives. Our science-first approach and rapid yet rigorous clinical development means we seek excellence in everything we do for customers and our teammates. Inspired by our work, and the talented team members who work with us, we're united in our collective goal to bring about improved, lasting patient outcomes. Join us in building a better future. The OpportunityCala Health is seeking a Senior or Principal Quality Engineer to join our growing team. The role will report to the Director, Quality Assurance and Compliance.Specific Responsibilities also include:

• Support commercial device manufacturing and new product introduction
• Identify and implement continuous process improvements
• Create test plans, manage test execution and write reports
• Document, investigate and resolve quality issues
• Initiate and process NCMRs, CAPAs and deviations as needed
• Create, route and approve document change orders
• Develop and report quality system metrics.
• Support internal and external audits
• Contribute to risk management content such as FMEA, hazard analysis and requirements trace matrices
• Ensure processes maintain compliance with regulatory requirements.
• Support company goals and objectives, policies and procedures, the Quality System Regulation, ISO/MDD regulations, and other regulatory requirements
• Other quality engineering duties and support as neededDesired Skills and Experience:We are looking for a Senior or Principal Quality Engineer to support the Cala quality team in a dynamic, fast-paced startup environment, exemplified by:
  • BS or MS Engineering degree or equivalent
  • Minimum 7 years work experience, preferably in a technical capacity and/or in a medical device company
  • Working knowledge of ISO 13485 and 21 CFR 820 is preferred
  • Flexibility in working in a fast pace, dynamic environment
  • Works independently with minimum oversight
  • Strong computer skills and experience, including Microsoft Office products
  • Strong interpersonal, analytic and organizational skills
  • Process orientation when planning and performing work
  • Ability to understand and interpret written material as well as explain those materials to team members and employees
  • Good writing and communication skillsCala Health believes our success is based on diversity of people, teams and thinking. We offer all employees the tools, training and mentoring they need to succeed. Our selection process is driven by the key requirements for the role rather than bias or discrimination onthe basis of a candidate's sex, gender identity, age, marital status, veteran status, non-job- related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification. If you or someone you know might be interested in this position, please submit a resume & an introductory email to careers@CalaHealth.com.

Keywords: Cala Health, San Mateo , Principal Quality Engineer, Engineering , San Mateo, California